Non-Interventional Post Marketing Surveillance Study To Observe The Safety And Efficacy Of Vfend® Tablet In Korea

This study has been completed.

Sponsor:

Pfizer

ClinicalTrials.gov Identifier:

NCT01073631

First Posted: February 23, 2010

Last Update Posted: June 7, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Percentage of Participants With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable [ Time Frame: Baseline (Day 1) up to 2.1 Years ]

Clinical response defined as: Cure=resolution of all baseline signs and symptoms of fungal infection(s); Improvement=lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure=no improvement or deterioration of baseline condition; Unevaluable=incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up).

Secondary Outcome Measures:

Percentage of Participants With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not Evaluable [ Time Frame: Baseline (Day 1) up to 2.1 Years ]

In case cultivation performed, cultivated strain before and after Vfend administration recorded, and the improvement of mycological outcomes after administration evaluated. Mycological response defined as: Eradication=absence of signs and symptoms of fungal infection; Persistence=(no eradication) presence of fungal infection; Superinfection=existence of different strains from strains separated prior to study treatment; Not evaluable=a follow-up mycological cultivation not performed.

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Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Patients who are indicated for voriconazole tablet according to the drug package insert.

Criteria

Inclusion Criteria:

Patients who are indicated for voriconazole table according to the drug package insert.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073631